Entering the US food market is a complex journey. Biosafe specializes in steering the GRAS notice through the FDA’s intricate submission process, ensuring your products meet U.S. safety regulations. With a step-wise, personalised approach including but not limited to Scientific Data Compilation, Documentation and Dossier Preparation, and Regulatory Support Post-Submission, we are committed to our clients' success. Find out more about our GRAS notice consulting services here and book a meeting with our experts Paula Pescador and Anne Ukkonen: https://lnkd.in/e-NvfDNz #FoodSafety #FDA #GRAS #RegulatoryCompliance #Biosafe
Biosafe
Research Services
Your pathway to safer new food solutions. #foodsafety #scientificassessment #laboratoryresearch #EUlegislation
About us
Unlocking Food and Feed Product Approval with Biosafe 🌍 Helping you navigate European and global regulations | 🚀 Bridging the gap between science and compliance At Biosafe, we are dedicated to helping our customers navigate the complex landscape of food and feed product approval in the EU and beyond. Whether you're in the midst of product development or seeking regulatory approval, we have the expertise and capabilities to support you every step of the way. 🔬 Comprehensive services to ensure compliance: ✔️ Safety assessment of viable microorganisms, feed additives, food enzymes, fermentation products, novel foods and microbial plant protection products following EFSA guidance requirements ✔️ Expertise in microbiology, molecular biology, in vitro toxicology, and bioinformatics ✔️ Regulatory consulting and dossier preparation ✨ Expertise tailored to your needs: ✔️ In-depth knowledge of legislative requirements, guidelines, and the EU decision-making process ✔️ Pragmatic execution utilising cutting-edge laboratory techniques ✔️ Our team deeply understands problem-solving principles, scientific writing, and effective communication, bridging the gap between experts and non-experts 💡 Embracing innovation for a better future: We actively explore new possibilities for the wider application of our knowledge and methods to shape a safer and more sustainable food industry. 🤝 Your trusted partner for success: Count on us to be your reliable and supportive partner, providing tailored solutions and guidance throughout your regulatory journey. Join the Biosafe community today and unlock the potential of your food and feed innovations. 👩🏾🔬🧑🏼🔬👨🏽🔬 As part of our team, you'll have the opportunity to work alongside experts in the field, collaborate with leading industry players, and be at the forefront of scientific advancements. Apply now at careers.biosafe.fi and be part of Biosafe's journey towards a safer, sustainable, and compliant food industry.
- Sivusto
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https://www.biosafe.fi
External link for Biosafe
- Toimiala
- Research Services
- Yrityksen koko
- 11–50 työntekijää
- Päätoimipaikka
- Kuopio
- Tyyppi
- Yksityisomistuksessa
- Perustettu
- 2014
- Erityisosaaminen
Sijainnit
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Ensisijainen
Microkatu 1
Kuopio, 70210, FI
Työntekijät Biosafe
Päivitykset
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Biosafe is #hiring! We are looking for Regulatory Specialists to join our expert team and work on the safety assessment of biotechnological food and feed products on a global scale. We're located in Kuopio, Finland, but we offer fully remote work possibilities within the EU. You're a great candidate for us if you: → Have a Master’s degree in biotechnology, food science, or a similar relevant field (PhD is an advantage) → Have 3+ years of experience in regulatory affairs within the food/feed industry, government agencies or authorities, or a relevant company → Are fluent in English, both written and spoken (other languages are a plus) and → Have extensive knowledge about EU and/or US food legislation If you are passionate about contributing to innovative food safety solutions, we’d love to hear from you. Read more and apply here, we'll be processing applications soon as we receive them! #RegulatoryConsultant #RegulatorySpecialist #RegulatoryCompliance #FoodSafety #Microbiology #Biotechnology #Biosafe #JobOpportunity #NowHiring #Recruiting
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Bioinformatic analysis in microbial genome research is rapidly evolving, with the new EFSA statement presenting both opportunities and challenges. Learn more about the role of bioinformatics in microbial safety assessments and how Biosafe navigates these complexities in our latest article: https://lnkd.in/eEd8PkDb Stay informed about how Biosafe is navigating these changes and leading in food safety by participating in our upcoming webinars! #Bioinformatics #GenomeAnalysis #Microbiology #RegulatoryCompliance #Biosafe
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The latest EFSA Statement on WGS analysis was published this month, replacing the 2021 statement. It contains some interesting new requirements and recommendations: → Long read or hybrid sequencing & assembly methods are required for bacterial strains and some viruses. → A 99 % similarity threshold is given for ANI-based identification of yeasts and filamentous fungi, with the ANI value lowered to 94 % for bacteria. → Bioinformatic search of metabolic pathways for the production of antimicrobials may be required from some taxa. → Plus, several updates in data submission & formats. At Biosafe, we are reading the new statement carefully and implementing these changes in our service pipeline. Read the full statement here: https://lnkd.in/dzaBs8sn #EFSA #Biosafe #WGS #WholeGenomeSequencing
EFSA statement on the requirements for whole genome sequence analysis of microorganisms intentionally used in the food chain
efsa.onlinelibrary.wiley.com
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Only a few days left to save 600 € per MIC test for antimicrobial susceptibility testing! Order your tests here: https://lnkd.in/eXW8hpDm
Biosafe is offering a special discount on MIC tests for aerobic gram-negative and anaerobic gram-negative and -positive bacteria. Save 600 € on each antimicrobial susceptibility test during this limited-time offer in August. #Biosafe's protocols are designed to meet official requirements to ensure that you achieve successful regulatory approval. Don't miss out—learn more and place your order here: https://lnkd.in/eXW8hpDm #Microbiology #LaboratoryServices #SpecialOffer #MICtests #Antimicrobial
Antimicrobial susceptibility test (MIC) | Biosafe
biosafe.fi
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Biosafe is offering a special discount on MIC tests for aerobic gram-negative and anaerobic gram-negative and -positive bacteria. Save 600 € on each antimicrobial susceptibility test during this limited-time offer in August. #Biosafe's protocols are designed to meet official requirements to ensure that you achieve successful regulatory approval. Don't miss out—learn more and place your order here: https://lnkd.in/eXW8hpDm #Microbiology #LaboratoryServices #SpecialOffer #MICtests #Antimicrobial
Antimicrobial susceptibility test (MIC) | Biosafe
biosafe.fi
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Requirements for whole genome sequence analysis develop rapidly. We at #Biosafe are reading this EFSA statement carefully and implementing the changes in our service pipeline.
EFSA statement on the requirements for whole genome sequence analysis of microorganisms intentionally used in the food chain
efsa.onlinelibrary.wiley.com
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Throughout July, you can save 1000 € per cytotoxicity test for Bacillus strains in food and feed applications. Biosafe performs in vitro cytotoxicity tests using Vero cells, adhering to #EFSA recommendations. Our protocols are meticulously designed to meet official standards, ensuring smooth regulatory approval. Order here, and read more information about samples and schedules: https://lnkd.in/gBRbYTdD #Biosafe #LaboratoryServices #CytotoxicityTests #Bacillus #FeedAdditives #FoodAdditives
Cytotoxicity tests | Biosafe
biosafe.fi
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Summer is here, but there are no breaks for food safety and regulatory compliance needs! Biosafe's dedicated team will be available throughout the summer to support your analyses and projects and ensure timely compliance. Whether its expert advice or laboratory services, we're here to help. Reach out to us for all your food and feed safety needs! https://lnkd.in/eEv3mX99 #Biosafe #FoodSafety #FeedSafety #EFSA #RegulatoryCompliance
Contact us | Biosafe
biosafe.fi
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Biosafe's team is in Amsterdam for the 3rd Fermentation-Enabled Alternative Protein Summit! Europe’s flagship precision and biomass fermentation event is turning out to be fantastic, and we've already listened to some insightful speeches, and had some excellent discussions with colleagues. Dr. Pauliina Halimaa's session is at 10:30am tomorrow, so if you are at the summit, we're looking forward to seeing you there! #Biosafe #FermentationSummit #AlternativeProteins #FoodInnovation #NovelFoods
Lovely to be here again this year! Tomorrow I will be talking about how alternative proteins are authorised. #FEAP2024